INDICATIONS

For active immunization of puppies aged 4 weeks and older to prevent clinical signs and mortality from canine distemper virus and canine parvovirus infection, and to prevent virus shedding after canine distemper virus and canine parvovirus infection.

IMMUNITY

Onset of immunity: 7 days to canine distemper virus.

3 days to canine parvovirus.

Duration of immunity: 8 weeks.

This vaccine stimulates active immunity in puppies against canine parvovirus and canine distemper virus. Maternal antibodies against canine parvovirus do not affect the efficacy of this product. Immunity against canine distemper virus is achieved in puppies at 4 weeks of age with low to medium levels of maternal antibodies.

COMPOSITION

Nobivac® Puppy DP PLUS is a combination of live attenuated strains of canine distemper virus and canine parvovirus. Each vial contains one dose for reconstitution.

Each dose (1 ml) of reconstituted vaccine contains:

Live strain of canine distemper virus Onderstepoort 10 5.1 – 10 6.5 TCID 50

Live strain of canine parvovirus 630a 10 5.1 – 10 6.7 TCID 50

STORAGE INSTRUCTIONS

Store in the refrigerator at 2 °C to 8 °C.
Do not freeze.
Protect from light.
Avoid prolonged or repeated exposure to high ambient temperatures.
Allow the vaccine to gradually reach room temperature (20 °C to 25 °C) before use.
The diluent can be stored at room temperature (20 ºC to 25 ºC).
Do not freeze the diluent.
WARNINGS

Vaccinate healthy puppies only.
Adequate clinical examination must be performed before vaccination.
DO NOT mix Nobivac ® Puppy DP PLUS with any other vaccine or immunological product, except those specifically mentioned in the section INTERACTION WITH OTHER MEDICINES. There is no information on the compatibility of this vaccine with any other vaccine or drug.
Avoid overdose or underdose of the vaccine.
Do not administer the product intravenously.
Moderate or high levels of maternal antibodies against canine distemper virus may reduce the effectiveness of the Nobivac® Puppy DP PLUS vaccine against canine distemper virus. Do not open or reconstitute the vaccine until you are ready to vaccinate.
The vaccine should be diluted with the supplied diluent (Nobivac ® Diluent) immediately before use.
As with all vaccines, anaphylactic or hypersensitivity reactions may occur.
Accidental self-injection may result in serious allergic reactions.
In the event of accidental self-injection, seek medical advice immediately and show the instructions for use to the physician.
KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
Although this vaccine has been thoroughly tested under a wide range of conditions, failure may occur for a variety of reasons. If suspected, seek veterinary advice and notify the Registration Holder.
PRECAUTIONS

Observe aseptic precautions. Ensure that all vaccination equipment (containers, syringes and needles) are clean and sterile before and during use. Use sterile equipment when administering the vaccine.
Do not use disinfectants or antiseptics to sterilize any equipment.
It is good vaccination practice to avoid contact of the vaccine with the eyes, hands and clothing.
Do not eat, drink or smoke while handling the product.
Use the entire contents after first opening the vial and do not store partially used vials for future use.
Hypersensitivity reactions following administration are rare, but as with all vaccines, they can occasionally occur. In this case, an injection of epinephrine subcutaneously may be indicated.
Destroy any unused vaccine and dispose of all vaccine containers and disposable equipment after use in accordance with the National Environmental Protection Act: Waste Act 2008 (Act No. 59 of 2008).
Do not pollute rivers, dams or any water source with containers or waste.
SPECIAL PRECAUTIONS FOR USE

In some puppies, the canine parvovirus vaccine strain may be detectable in the faeces for up to 8 days after vaccination. Occasionally, this virus may be spread to other dogs but will not cause clinical signs of disease. Canine distemper virus is not spread by vaccinated puppies.

ADVERSE REACTIONS

A small, painless swelling (maximum 1 cm in diameter) at the injection site is very common during the first week after vaccination. The swelling will go away completely within a few days.
During or immediately after vaccination, it is very common to see whining and/or scratching at the injection site in your pet.
In very rare cases, Nobivac ® Puppy DP PLUS may cause a hypersensitivity reaction. 

sensitivity, including anaphylaxis (sometimes fatal). In case of anaphylaxis, appropriate treatment should be instituted immediately.
The occurrence of adverse reactions is defined using the following rules:

very common (more than 1 in 10 treated animals shows adverse reactions)
common (more than 1, but less than 10 animals out of 100 treated animals)
uncommon (more than 1, but less than 10 animals out of 1,000 treated animals)
rare (more than 1, but less than 10 animals out of 10,000 treated animals)
very rare (less than 1 animal out of 10,000 treated animals, including isolated reports).
INTERACTION WITH OTHER MEDICINES

There are safety and efficacy data that show that Nobivac ® Puppy DP PLUS can be administered on the same day, but not mixed with Nobivac ® series vaccines containing Bordetella bronchiseptica and canine parainfluenza virus components for intranasal administration. Efficacy after concomitant administration has not been tested.

DOSAGE AND ADMINISTRATION – USE ONLY AS DIRECTED.

Reconstitute single dose vial (1 ml) and administer subcutaneously into the neck or chest.

Administer 1 dose (1 ml) of Nobivac® Puppy DP PLUS to puppies aged 4 weeks and over.

Administer the entire contents of the vial. Ensure that the lyophilized swab is fully reconstituted before use. The reconstituted product is a pink or rose-colored suspension.

PRESENTATION

Lyophilisate: off-white or cream-colored lyophilized granulate in a transparent glass vial type I, closed with a chlorobutyl rubber stopper and an aluminum cap. Each vial contains 1 dose.

Solvent (1 ml): clear, colorless solution in a transparent glass vial type I of 1 ml, closed with a bromobutyl rubber stopper and an aluminum cap.

Plastic tray with 5 vials of vaccine with 1 dose and 5 vials containing 1 ml of solvent.

Plastic tray with 25 vials of vaccine with 1 dose and 25 vials containing 1 ml of solvent.